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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000020304
Receipt No. R000023428
Scientific Title Multicentric survey of acute on chronic liver failure in Japan
Date of disclosure of the study information 2015/12/22
Last modified on 2018/06/24

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Basic information
Public title Multicentric survey of acute on chronic liver failure in Japan
Acronym Multicentric survey of ACLF in Japan
Scientific Title Multicentric survey of acute on chronic liver failure in Japan
Scientific Title:Acronym Multicentric survey of ACLF in Japan
Region
Japan

Condition
Condition Acute on chronic liver failure
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the outocme of patients with ACLF seen between 2011 and 2014 retrospectively.
Basic objectives2 Others
Basic objectives -Others Trend
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes APASL definition of ACLF
Key secondary outcomes EASL-CLIF consortium definition of ACLF
Diagnostic criteria of Chinese Medical Association (CMA)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria APASL criteria
CMA criteria
EASL-CLIF Consortium criteria
Key exclusion criteria APASL criteria
CMA criteria
EASL-CLIF Consortium criteria
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Mochida
Organization Saitama Medical University
Division name Department of Gastroenterology & Hepatology
Zip code
Address Morohongo 38, Moroyama-Machi, Saitama, Japan
TEL 049-2761198
Email alfsg@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Nakayama
Organization Saitama Medical University
Division name Department of Gastroenterology & Hepatology
Zip code
Address Morohongo 38, Moroyama-Machi, Saitama, Japan
TEL 049-276-1198
Homepage URL
Email alfsg@saitama-med.ac.jp

Sponsor
Institute Health Labour Sciences Research Grant, Research on Measures for Intractable Diseases from the Ministry of Health, Labor and Welfare of Japan
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant, Research on Measures for Intractable Diseases from the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We conducte a pilot study on ACLF in Japan.

Management information
Registered date
2015 Year 12 Month 22 Day
Last modified on
2018 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023428

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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